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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Electromyograph, Diagnostic
510(k) Number K993878
Device Name JE 2000
Applicant
Jack'S Electrodes
2227 E. Crescent Dr.
Altadena,  CA  91001
Applicant Contact ANTHONY R.H. FENDER
Correspondent
Jack'S Electrodes
2227 E. Crescent Dr.
Altadena,  CA  91001
Correspondent Contact ANTHONY R.H. FENDER
Regulation Number890.1375
Classification Product Code
IKN  
Date Received11/15/1999
Decision Date 02/01/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Physical Medicine
510k Review Panel Neurology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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